MAUDE Adverse Event Report: AVALIGN GERMAN SPECIALTY INSTRUMENTS MILLENNIUM SURGICAL CORP; K-WIRE

Model Number Z16113001

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device not returned for evaluation by manufacturing.

Event Description

K-wire was inserted into vertebral bone.Screw was placed overk-wire, k-wire was screwed into the space and the tip of the k-wire broke off.

• Brand Name: MILLENNIUM SURGICAL CORP
• Type of Device: K-WIRE
• Manufacturer (Section D): AVALIGN GERMAN SPECIALTY INSTRUMENTS; 626 cooper ct; schaumburg IL 60173
• Manufacturer (Section G): AVALIGN GERMAN SPECIALTY INSTRUMENTS; 626 cooper ct; schaumburg IL 60173
• Manufacturer Contact: jennifer staunton ; 626 cooper ct; schaumburg, IL 60173 ; 8479080292
• MDR Report Key: 9630175
• MDR Text Key: 204048610
• Report Number: 1421101-2020-00002
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 00190776135072
• UDI-Public: 00190776135072
• Combination Product (y/n): N
• PMA/PMN Number: K100736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: Z16113001
• Device Catalogue Number: Z16113001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1